Abstract: I have been in the cosmetics industry for nearly 45 years, and for 18 of them, I have written about regulations for Cosmetics & Toiletries magazine. Sadly, this will be my penultimate column, and a reflection of my time in the industry.

I have been in the cosmetics industry for nearly 45 years, and for 18 of them, I have written about regulations for Cosmetics & Toiletries magazine. Sadly, this will be my penultimate column, and a reflection of my time in the industry. My final column will be about the future of cosmetic regulations.

As I began to think about my years, I realized that the industry has suffered a thousand little cuts. None of these are fatal, but their accumulation continues to make the industry bleed, and without a solution, the industry will continue to suffer. Below are examples of the cuts the cosmetics industry has endured over the past 45 years.

Carbon Black and Pigments

In 1976, the U.S. Food and Drug Administration (FDA) banned the dye amaranth, better known as FD&C Red No. 2 (CI 16185). This was based on findings from an animal feeding study conducted in the Soviet Union that the pigment could potentially cause cancer. Since the study took place during the Cold War, many scientists questioned it. Nevertheless, it had to be banned due to the Delaney Clause, which prohibited the use of any chemical found to induce cancer in man or animals. Other studies found no hazard with amaranth, and even the FDA’s studies were inconclusive. Red 2 is still allowed just about everywhere except the United States. When it was banned, it was the most popular red dye in the cosmetics industry.

Also in 1976, the important color carbon black (Black 2, CI 77266) was banned in the United States because the industry could not prove the absence of polyaromatic nuclear hydrocarbons (PAHs). The FDA finally allowed carbon black again on July 16, 2004, with specifications for PAHs, benzo(a)pyrene and dibenz(a,h)anthracene, and required each batch to be certified by the FDA. Israel is left as the only market where carbon black is still prohibited.

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I have been in the cosmetics industry for nearly 45 years, and for 18 of them, I have written about regulations for Cosmetics & Toiletries magazine. Sadly, this will be my penultimate column, and a reflection of my time in the industry. My final column will be about the future of cosmetic regulations.

As I began to think about my years, I realized that the industry has suffered a thousand little cuts. None of these are fatal, but their accumulation continues to make the industry bleed, and without a solution, the industry will continue to suffer. Below are examples of the cuts the cosmetics industry has endured over the past 45 years.

Carbon Black and Pigments

In 1976, the U.S. Food and Drug Administration (FDA) banned the dye amaranth, better known as FD&C Red No. 2 (CI 16185). This was based on findings from an animal feeding study conducted in the Soviet Union that the pigment could potentially cause cancer.1 Since the study took place during the Cold War, many scientists questioned it. Nevertheless, it had to be banned due to the Delaney Clause, which prohibited the use of any chemical found to induce cancer in man or animals. Other studies found no hazard with amaranth, and even the FDA’s studies were inconclusive. Red 2 is still allowed just about everywhere except the United States. When it was banned, it was the most popular red dye in the cosmetics industry.

Also in 1976, the important color carbon black (Black 2, CI 77266) was banned in the United States because the industry could not prove the absence of polyaromatic nuclear hydrocarbons (PAHs). The FDA finally allowed carbon black again on July 16, 2004, with specifications for PAHs, benzo(a)pyrene and dibenz(a,h)anthracene, and required each batch to be certified by the FDA. Israel is left as the only market where carbon black is still prohibited.

For more than 25 years, American women were deprived of this intense black pigment, which is popular in mascaras worldwide. Although in reality, it did not stop consumer use as women brought mascaras formulated with the pigment back after international travel. And more recently, shopping on the Internet eliminated many regional sales boundaries.

In a small way, this author had a part in the FDA allowing the return of carbon black. After attending an international meeting on the harmonization of cosmetic regulations, he was engaged by the FDA to conduct a simple study—since the FDA’s color policies were strongly criticized at the meeting. All colors allowed in both Japan and the EU but not permitted in the United States were re-assessed, and the potential for carbon black’s use was also examined. While there were many colors to consider, only four were of interest: carbon black, quinacridone red (CI 73915), quinacridone violet (CI 73900) and red 2.

Then in 1987, the Cosmetics, Toiletry and Fragrance Association (CTFA), now the Personal Care Products Council (PCPC), submitted a citizen’s petition for carbon black, and it was finally allowed in 2004. The quinacridones are still sitting on someone’s desk at the FDA. In 1994, the FDA approved the use of red 40 (CI 16035) in eye area cosmetics, along with Blue 1, Green 5 and Yellow 5, which allowed U.S. manufacturers to make brilliant eye cosmetics. With this approval, interest in red 2 faded away, although it still remains popular in every other country.

Ingredient Labeling

In the 1970s, the second cut occurred with ingredient labeling on cosmetics, which intially caused a great deal of turmoil but by the 1980s, became just a minor annoyance. Then about 10 years ago, it re-emerged as a real pain and the cosmetic industry has since spent significant time and money to accomplish little toward the original intent of listing ingredients for comparison and allergen considerations.

Congress first became interested in labeling cosmetics in the early 1970s. Around the same time, Norman Estrin, PhD, and Jim Merritt from the CTFA met with Virginia Knauer, consumer advisor to the president, to update her on the CTFA’s creation of the first edition of the International Cosmetic Ingredient Dictionary, which served as a reference to harmonize cosmetic ingredient names. While the cosmetics industry opposed ingredient labeling, when the FDA later proposed it, the dictionary was in place. The FDA accepted these names and the first edition was published in 1973.

To develop the dictionary, the CTFA set up the Cosmetic Ingredient Nomenclature Committee to identify names for cosmetic ingredients. This committee included a non-voting representative from the FDA, who provided advice. The committee decided this International Nomenclature of Cosmetic Ingredients (INCI) would be used to name similar chemicals, and that every chemical would not have a separate name. Mixtures were indicated by listing the separate chemicals with the word and in parentheses, between them. Thus, a mixture of isopropyl myristate and butyl stearate appeared as: Isopropyl Myristate (and) Butyl Stearate. However, mixtures like stearic acid consisting of C–14, C–16, C–18 and possibly C–18-2H was called simply Stearic Acid, even though it was only 45% actual C–18 stearic acid.

When a manufacturer detailed its ingredients, the listing was to appear in descending order of predominance, down to 1%. Ingredients used below 1% could be listed in any order, and colors had the option of being listed last. Also, on the label, in the case of mixtures, the (and) was not to be included. The exception to these rules was when the FDA issued confidentiality to an ingredient, in which case it could be listed as, “and other ingredients.” The INCI designation for ingredients containing water excluded the word water, although it was still required to be listed on the ingredient label. Cosmetic companies quickly feared the loss of their “trade secret” ingredients and formulations but this fear disappeared, since knowing the ingredient label was not valuable in reverse-engineering the formulation.

When the FDA never took action for incorrect ingredient labels, the cosmetic industry took advantage of this vacuum. Ingredient suppliers hid the actual composition of their ingredients, while finished goods houses ignored many labeling rules. A favorite of this author’s, from the 1970s, is the use of aloe vera gel. This ingredient is about 99% water but since its water phase is gel, many companies never even listed water as an ingredient. Water should be listed first on the label in this case.

Advertising in ingredient labels is also forbidden, but no action was taken by the FDA. Terms like purified, distilled or Rocky Mountain water; natural glycerin and vitamin soon appeared on ingredient labels. As many formulators know, “purified water” is the drug name for water, so using this incorrectly makes a drug claim. While all of these terms were prohibited, the industry was not stopped from using them.

The CTFA also had to face the public’s reaction to all these strange and unpronounceable words listed as cosmetic ingredients. As the Internet did not exist in the 1970s, and personal computers were rare, research was conducted at public libraries. So to be sure the public could find help, the CTFA offered a copy of the International Cosmetic Ingredient Dictionary to all libraries. The response was underwhelming to say the least: The New York Public Library on 42nd Street in Manhattan wanted a copy, as did the Library of Congress. So the FDA’s idea for ingredient labeling really only aided two groups: ingredient suppliers, who could now learn who used their ingredients and obtain leads when they were not selling to that company; and formulators, who understood ingredient labels.

After the initial anxiety in the 1970s, ingredient labeling issues died down until other countries adopted the use of INCI names. The EU insisted using Latin names; Quebec insisted on French; and Mexico wanted everything in Spanish. Harmonization has been an ongoing issue, with no end in sight. More recently regarding labeling, the EU, in its 7th Amendment to the Cosmetic Directive, added that 26 allergens found commonly in fragrances, flavors and essential oils, should be labeled if found above 10 ppm in leave-on products, and 100 ppm in rinse-off products. More clutter with no benefits. Even the EU’s Scientific Committee has indicated that some of these chemicals are not really allergens, but the cut still bleeds.

Non-governmental Organizations

In the late 1970s and early 1980s, the People for the Ethical Treatment of Animals (PETA), one of the first non-government organizations (NGOs) to attack the cosmetic industry, made the television news. The group of animal rights activists dressed up like bunnies with bloody, teary eyes and demonstrated at cosmetic company headquarters and industry events. At the time, the industry did not explain to consumers that the animals used for tests were bred for that purpose and necessary to ensure human safety. Instead, the industry said that it would spend loads of money and do away with animal testing on cosmetics and ingredients. This is not possible, and even the EU, which has banned the use of animal testing, has acknowledged there are no replacements for certain tests. In 2013, this ban on all animal testing of raw materials went into effect.

‘Free-from’ Claims

In the early 1980s, the cosmetics industry started down a troubled road when a marketer discovered more products would sell by advertising what is not in them rather than what is. This started with the claim PABA-free and it shows no signs of ending. When the FDA published the first sunscreen regulations in 1978, the most popular sunscreen active was padimate O (INCI: Ethylhexyl Dimethyl PABA). In contrast, PABA (aminobenzoic acid) was rarely used; it is found in nature and is water-soluble but stains fabrics and must be applied 30 min before sun exposure to offer any protection. The FDA allowed sunscreen producers to claim “contains PABA,” even though their active was padimate O, not PABA. In the early 1980s, the major marketers of the UV filter octinoxate (INCI: Ethylhexyl Methoxycinnamate) promoted this as an alternative to padimate O, and sunscreens quickly hit the market claiming PABA-free. The FDA should have taken action, since it originally found PABA to be safe and effective. Manufacturers making these claims also should have been required to prove PABA was unsafe or discontinue these claims.

Since the claim PABA-free sold products, the cosmetic industry started using claims for oil-free, chemical-free, paraben-free, sulfate-free, etc. Each time one of these claims hit the market, the press raised two points. 1. How many people were killed or injured by cosmetics before these dangerous chemicals were removed from them? and 2. Self-regulation is not working, so maybe the FDA should pre-approve all ingredients and cosmetics before they enter the market. If that ever happens, it will be a disaster for the cosmetic industry.

Canada was the first country, now joined by England and France, to virtually prohibit “free-from” claims on the grounds that they were inherently false and misleading. This claim was only allowed if a product containing that ingredient was sold legally in Canada before being removed. The company then had to notify Health Canada that the ingredient was removed, and supply documentation showing the ingredient was not present. Even then, the claim could only be made for one year, followed by removal of all products still labeled with the claim. The market in Canada has forced compliance, as stores did not want these products on their shelves and consumers were educated enough to see through these claims and not purchase “free-from” labeled products. There currently is a proposal before the EU Commission from France and England to prohibit this “free-from” claim in the EU.

However, the damage has already been done, as activists believed the advertising and assumed there are many unsafe ingredients in cosmetics. They have told consumers this, and are urging for more regulations along with the FDA’s pre-approval of products.

California

In 1986, under California’s Initiative and Referendum law, the voters passed the Safe Drinking Water Act, which became known as Proposition 65. Although not directed at the cosmetic industry, it applied to everything in California. The government was required to publish a list of chemicals it had found or suspected to cause cancer or reproductive harm. Retailers were then required to warn consumers if a one of their products contained a chemical that the State of California deemed to cause cancer or reproductive harm. Since there was a “bounty hunter provision,” allowing lawyers to get rich without proof, Prop. 65 quickly became a hemorrhaging cut to retail stores, and retailers dragged in product manufacturers, who dragged in the chemical industry, etc. The first time the cosmetic industry got caught up in Prop. 65 probably was with reports of lead in lipstick. This issue of trace levels continues to haunt the industry, and reports on television and the Internet still get major interest, even though the FDA agrees that these insignificant levels are safe.

On July 20, 2013, lawyers specializing in Prop. 65 cases applied to the States’ Attorney General to go after 137 companies for titanium dioxide issues and another 28 companies for cocamide DEA. The result? They were given free reign to blackmail the industry.

Environmental Working Group

Probably the most deadly of all the cuts was the California Safe Cosmetic Act of 2005. This required all cosmetics sold or produced in California to be registered if they contained any “ingredient”—not “chemical,” as referred to by Prop. 65—on the state’s published list. This law is simple but complying with it is time-consuming for companies. The real danger came from how the act was passed and subsequent actions. Sen. Carole Migden introduced it in her “lame duck” session, and the bill was supported and possibly written by the Environmental Working Group (EWG). Although the bill has little impact on cosmetic companies, since registering is the only requirement, it does show a shift by the EWG to challenge the cosmetic industry on the state level rather than the federal level.

In relation, in 2010, H.R. 5786 was introduced by Rep. Jan Schakowsky. Clearly, in this author’s view, this bill was either written by the EWG or its surrogate, and was never read by Schakowsky. This bill would ban the very hair dyes she uses. The bill went nowhere but continues to be re-introduced. It even drove Congress to hold a public hearing. The major components included: removing the hair dye exemption, mandatory registration for cosmetics and their ingredients, user fees, more warnings, label requirements such as for all contaminants above 1 ppb, etc. So far, these types of bills have gone nowhere.

As noted, NGOs have found more fertile ground by going after individual states. Washington and Minnesota have passed laws regulating cosmetics. Especially troublesome is the Minnesota law H.R. 458. Effective as of Aug. 1, 2015, no retailer may sell a children’s product that intentionally contains formaldehyde or chemically degrades to release formaldehyde under normal temperatures. Note that formaldehyde is found in ppm in almost all fatty acids, fatty alcohols and products made from them. Further, as of Aug. 1, 2013, a formulator cannot replace formaldehyde or chemicals that chemically degrade to release formaldehyde with any chemical known to federal, state or international agencies of being known or suspected to: a) harm the development of a fetus or child, or cause other development toxicity; b) cause cancer, genetic damage or reproductive harm; c) disrupt the endocrine or hormone system; and d) damage the nervous or immume system, organs, or cause other systemic toxicity. Other states where bills were recently introduced include Oregon, Maine and Massachusetts.

The Recast

This list of cuts would not be complete without Regulation (EC) No. 1223/2009, the EU’s recast of the Cosmetic Directive (Council Directive 76/768/EEC), which went into effect in July 2013. The first cut from this recast came from banning more than 1,300 chemicals from cosmetics. This ban is beyond logic, however, as no more than 10 or 15 of these chemicals have ever been used in cosmetics. Further, EU cosmetic formulators were not using most of these ingredients, such as benzene, arsenic, hydrogen cyanide or petroleum. Of course, U.S. activists twisted this recast into showing that current FDA regulations do not work, especially since it only prohibits about 12 chemicals whereas the EU banned more than 1,300. While the FDA may only prohibit 12, it does not allow the use of a significant number of chemicals in cosmetics, such as colors that have not been approved by the FDA or active pharmaceutical ingredients that have no cosmetic purpose.

In the recast’s Cosmetic Safety Report, a quantitative and qualitative listing of the composition of a cosmetic is required, listed out to the 4th decimal point; INCI names are disregarded. All mixtures are required to show all components, again disregarding INCI names. The Responsible Person (RP) sometimes uses the Material Safety Data Sheet (MSDS) as the source of the composition but this is not the true purpose of the MSDS and it does not list a complete composition of the chemical. Also, the EC wants a full fatty acid breakdown of some products but accepts INCI for others. Is olive oil a separate product or a complex mixture of triglycerides, fatty acids and other parts? When this is really important, the EU hides the facts. For example, it uses the words alcohol denat. but never requires identification of the denaturing agents. Yet the EU lets a manufacturer leave this information out of its Cosmetic Safety Report. Some RPs go even further by demanding that the composition be listed on the label’s ingredient. Why not just abolish INCI names altogether?

Several years ago, this author rushed to Boston to attend a hearing of the Commonwealth of Massachusetts’ Assembly. The state was holding public hearings on many safety bills, and one dealt with cosmetics. That bill required the full disclosure of the ingredient list of every chemical present in any cosmetic; it was written by a surrogate for the EWG. The most impressive statement presented was from a woman who made a soothing balm in her kitchen and sold this in natural health food stores. She testified that she bought her extra virgin olive oil, cocoa butter and lavender oil at a grocery store. She presented a jar with the ingredients labeled by these three names; perhaps she had never heard of INCI. She then opened an accordion portfolio of papers and started to unfold sheet, after sheet, after sheet, stating these were just some of the chemicals found in olive oil. She went on to pull more sheets on the other two ingredients. The chairman asked her to stop, saying he got the point. The bill was killed.

Retailers

The last cut listed here is the trend for retailers to dictate what ingredients are allowed in the products sold in their stores. This follows the cosmetic companies who have “black-listed” many ingredients. This probably started when Whole Foods Markets dictated what would or would not be allowed in its stores; the list contains more than 400 ingredients now. When will this madness end?

Comments

This author could come up with many more minor cuts that are slowly draining the cosmetics industry. Certainly REACh, Australia’s National Industrial Chemicals Notification and Assessment Scheme (NICNAS), and the Canadian Environmental Protection Act (CEPA) registrations are making new ingredients much more costly. Readers are invited to submit their ideas on the Cosmetics & Toiletries magazine LinkedIn group.

The cosmetic industry has failed to communicate to consumers and the press about the safety of products. Self-regulation works, as no company would deliberately put an unsafe cosmetic on the market. Who would buy it? A television journalist once asked this author, “Is it true that the regulations of cosmetics have not changed in the U.S. since 1938?” To which, he replied, “In 1938, a law was passed requiring cosmetics to be safe. How would you like it to be changed? Safer than safe? Much safer than safe? Or maybe less safe?” She looked at me, rubbed her ear and said it was time to break for a commercial.

To leave this column on a slightly more upbeat note, there is some movement in California to change Prop. 65 and its “legalized blackmailing.” A.B. 227 by Assemblyman Mike Gatto would shield companies if they comply within 14 days of receiving the 60-day notice. This passed with a unanimous vote in the Assembly and now goes to the Senate. At least this allows manufacturers to add warning labels—although these have been shown to be totally ineffective in California—instead of paying out large fees.

Another proposed change is to require sufficient evidence that exposure to a chemical actually causes cancer or reproductive harm before listing it on Prop 65. No more suspected listings. In 2013, Governor Jerry Brown held stakeholder meetings to reform Prop. 65 or even have a new ballot initiative to correct all the abuses.

In closing, this author will conclude by quoting an old Pogo comic strip that states, “We have met the enemy, and he is us.”

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Sidebars

Biography: David C. Steinberg, Steinberg & Associates

David C. Steinberg founded Steinberg & Associates, a consulting firm based in Plainsboro, NJ, USA, in 1995. Co-founder of the graduate program in cosmetic sciences at Fairleigh Dickinson University, where he lectured for 18 years on cosmetic chemistry, Steinberg has more than 35 years of experience in marketing, technical service and regulatory affairs in the personal care industry. In addition, he was president of the Society of Cosmetic Chemists in 1991. Steinberg is a frequent speaker worldwide on cosmetic regulations and preservation as well as sunscreen and cosmetic ingredient chemistry. In 2009, he was honored as the first regulatory expert in personal care to be granted fellow status by the Regulatory Affairs Professional Society. He wrote the Alluredbook, Preservatives for Cosmetics, Third Edition.